Monthly Report: New Drug Approvals in China | August 2022

by Grace Wang Sep 09, 2022

Editor's Notes: New drugs in this article refer to

  • Innovative/improved new chemical drugs / biological products that have never been granted marketing authorization in or outside China;

  • Original/improved chemical drugs / biological products that have received marketing authorization outside China and are applying for marketing authorization in China;

  • First generic drugs in China.

*"First generic drug in China" refers to the first generic drug developed by Chinese companies and approved by China National Medical Products Administration (NMPA). Technically, generic drugs are not innovative/improved drugs according to Chinese drug regulations. Yet, first generics are still included in this article because they are new in the Chinese market.

Related Articles:

In August 2022, China NMPA approved 13 new drugs, including 9 chemical drugs and 4 biological products

1.      Boehringer Ingelheim's Empagliflozin Tablets;

2.      Suzhou Zelgen Biopharmaceuticals' Donafenib Tosilate Tablets;

3.      Beijing Sciecure Pharmaceutical's Compound Amino Acids (19) and Alanyl Glutamine Injection;

4.      Jinan Jingsheng Technology's Formoterol Fumarate Solution for Inhalation;

5.      Wego Terumo's Peritoneal Dialysis Solution (Lactate-G1.35%);

6.      Wego Terumo's Low Calcium Peritoneal Dialysis Solution (Lactate-G1.35%);

7.      Xi'an Libang Pharmaceutical's Melphalan Hydrochloride for Injection;

8.      Roche's Entrectinib Capsules;

9.      Pfizer's Palbociclib Tablets;

10.    MSD's Recombinant Human Papillomavirus 9-Valent Vaccine;

11.    SinoCellTech's Ripertamab Injection;

12.    GenSci's Recombinant Human Growth Hormone Injection;

13.    Shanghai Kaimao Biopharmaceutical's Human Interferon γ for Injection.

1. Empagliflozin Tablets

1

Generic Name

Empagliflozin Tablets

2

Brand Name

Jardiance (欧唐静)

3

Classification

Class 2.4 chemical drug

4

Application Type

New drug application (NDA), import

5

Marketing Authorization Holder (MAH)

Boehringer Ingelheim International GmbH

6

Approval Date

Aug. 30, 2022

7

Time from Application Acceptance to Approval

279 days

8

Priority Review

Yes

9

Target(s)

Sodium/glucose cotransporter 2 (SLC5A2)

10

Indication(s)

Previously approved:

Indicated ① as a single therapy / ② in combination with metformin hydrochloride / ③ in combination with metformin hydrochloride and sulphonylurea to improve glycemic control combined with diet and exercise for adults having type 2 diabetes mellitus.

Limitation of use:

Not recommended for treating type 1 diabetes mellitus or diabetic ketoacidosis.

Newly approved on Aug. 30, 2022:

Indicated for reducing the risks of cardiovascular death and hospitalization for heart failure in adults with heart failure.

2. Donafenib Tosilate Tablets

1

Generic Name

Donafenib Tosilate Tablets

2

Brand Name

Ze Pu Sheng (泽普生)

3

Classification

Class 2.4 chemical drug

4

Application Type

NDA

5

MAH

Suzhou Zelgen Biopharmaceuticals Co., Ltd.

6

Approval Date

Aug. 12, 2022

7

Time from Application Acceptance to Approval

293 days

8

Priority Review

No

9

Target(s)

Vascular endothelial growth factor receptor (VEGFR)

Serine/threonine-protein kinase B-raf (BRAF)

Platelet-derived growth factor receptor (PDGFR)

10

Indication(s)

Previously approved:

Indicated for treating unresectable hepatocellular carcinoma (HCC) in patients who have not received systemic therapy.

Newly approved on Aug. 12, 2022:

Indicated for treating radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) that is locally advanced or metastatic.

3. Compound Amino Acids (19) and Alanyl Glutamine Injection

1

Generic Name

Compound Amino Acids (19) and Alanyl Glutamine Injection

2

Brand Name

/

3

Classification

Class 1.5 chemical drug (according to the former classification system)

4

Application Type

NDA

5

MAH

Beijing Sciecure Pharmaceutical Co., Ltd.

6

Approval Date

Aug 12, 2022

7

Time from Application Acceptance to Approval

2,268 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

Indicated for providing parental nutrition and amino acid supplement for adult patients when enteral nutrition is infeasible, insufficient, or contraindicated.

4. Formoterol Fumarate Solution for Inhalation

1

Generic Name

Formoterol Fumarate Solution for Inhalation

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

Abbreviated new drug application (ANDA)

5

MAH

Jinan Jingsheng Technology Co., Ltd.

6

Approval Date

Aug. 30, 2022

7

Time from Application Acceptance to Approval

427 days

8

Priority Review

No

9

Target(s)

Beta-2 adrenergic receptor (ADRB2)

10

Indication(s)

For long-term aerosolized administration (twice daily: morning and evening) in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary diseases (COPDs), including chronic bronchitis and emphysema.

11

Notes

First generic drug in China

5. Peritoneal Dialysis Solution (Lactate-G1.35%)

1

Generic Name

Peritoneal Dialysis Solution (Lactate-G1.35%)

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Wego Terumo (Weihai) Medical Products Co., Ltd.

6

Approval Date

Aug. 12, 2022

7

Time from Application Acceptance to Approval

1,323 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

Indicated to be used in peritoneal dialysis for treating chronic kidney failure.

11

Notes

First generic drug in China

6. Low Calcium Peritoneal Dialysis Solution (Lactate-G1.35%)

1

Generic Name

Low Calcium Peritoneal Dialysis Solution (Lactate-G1.35%)

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Wego Terumo (Weihai) Medical Products Co., Ltd.

6

Approval Date

Aug. 12, 2022

7

Time from Application Acceptance to Approval

1,332 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

Indicated for peritoneal dialysis to treat chronic kidney failure.

11

Notes

First generic drug in China

7. Melphalan Hydrochloride for Injection

1

Generic Name

Melphalan Hydrochloride for Injection

2

Brand Name

/

3

Classification

Class 3 chemical drug

4

Application Type

ANDA

5

MAH

Xi’an Libang Pharmaceutical Co., Ltd.

6

Approval Date

Aug. 30, 2022

7

Time from Application Acceptance to Approval

1,721 days

8

Priority Review

Yes (for rare disease)

9

Target(s)

deoxyribonucleic acid (DNA)

10

Indication(s)

1. Indicated as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma;

2. Indicated as an expedient treatment for multiple myeloma patients not suitable for oral treatment.

11

Notes

First generic drug in China

8. Entrectinib Capsules

1

Generic Name

Entrectinib Capsules

2

Brand Name

Rozlytrek (罗圣全)

3

Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Roche Pharma (Schweiz) AG

6

Approval Date

Aug. 12, 2022

7

Time from Application Acceptance to Approval

271 days

8

Priority Review

No

9

Target(s)

ALK tyrosine kinase receptor (ALK);

Ros1 tyrosine kinase receptor;

Neurotrophic Receptor Tyrosine Kinase 1 (NTRK1);

BDNF/NT-3 growth factors receptor (TrkB);

NT-3 growth factor receptor (NTRK3).

10

Indication(s)

Indicated for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC).

9. Palbociclib Tablets

1

Generic Name

Palbociclib Tablets

2

Brand Name

/

3

Classification

Class 5.1 chemical drug

4

Application Type

NDA, import

5

MAH

Pfizer Japan Inc.

6

Approval Date

Aug. 12, 2022

7

Time from Application Acceptance to Approval

611 days

8

Priority Review

No

9

Target(s)

Cyclin-dependent kinase 4 (CDK4);

Cyclin-dependent kinase 6 (CDK6).

10

Indication(s)

Indicated for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in post-menopausal women.

10. Recombinant Human Papillomavirus 9-Valent Vaccine

1

Generic Name

Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine

2

Brand Name

GARDASIL 9 (佳达修9)

3

Classification

Class 3.1 prophylactic biological product

4

Application Type

Biologics License Application (BLA)

5

MAH

Merck Sharp & Dohme Corp.

6

Approval Date

Aug. 30, 2022

7

Time from Application Acceptance to Approval

503 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

Indicated for preventing diseases related to human papillomavirus (HPV). The target group was newly approved to expand from females 16-26 years of age to 9-45 years of age.

11. Ripertamab Injection

1

Generic Name

Ripertamab Injection

2

Brand Name

/

3

Classification

Class 2 therapeutic biological product

4

Application Type

BLA

5

MAH

SinoCellTech Group Ltd. 

6

Approval Date

Aug. 30, 2022

7

Time from Application Acceptance to Approval

981 days

8

Priority Review

No

9

Target(s)

/

10

Indication(s)

In combination with CHOP (cyclophosphamide, hydroxydaunorubicin, oncovin, and prednisone) regime for the treatment of diffuse large B-cell lymphoma.

12. Recombinant Human Growth Hormone Injection

1

Generic Name

Recombinant Human Growth Hormone Injection

2

Brand Name

Jintropin (赛增)

3

Classification

Class 3.2 therapeutic biological product

4

Application Type

BLA

5

MAH

GeneScience Pharmaceuticals Co., Ltd. (GenSci)

6

Approval Date

Aug. 4, 2022

7

Time from Application Acceptance to Approval

226 days

8

Priority Review

Yes (pediatric drug)

9

Target(s)

/

10

Indication(s)

Previously approved:

1. For treating children with slow growth caused by endogenous growth hormone deficiency.

2. For treating children with short stature caused by Noonan syndrome.

3. For treating children with short stature or growth retardation caused by SHOX deficiency.

4. For treating children with short stature due to achondroplasia.

5. For treating growth disorders in girls due to gonadal dysgenesis (Turner syndrome).

6. For treating Prader-Willi syndrome (PWS).

7. For treating adults with short bowel syndrome who receives nutritional support.

8. For treating growth hormone deficiency due to confirmed hypothalamic-pituitary disease and severe growth hormone deficiency confirmed by two different growth hormone stimulation tests.

9. For treating severe burn.

10. For treating children with short stature who are born small for gestational age (SGA).

Newly approved on Aug. 4, 2022:

11. For treating idiopathic short stature (ISS).

13. Human Interferon γ for Injection

1

Generic Name

Human Interferon γ for Injection

2

Brand Name

Ga Ma (伽马)

3

Classification

Class 3.2 therapeutic biological product

4

Application Type

BLA

5

MAH

Shanghai Kaimao Biopharmaceutical Co., Ltd.

6

Approval Date

Aug. 18, 2022

7

Time from Application Acceptance to Approval

532 days

8

Priority Review

Yes (innovative/improved new drug in shortage and with urgent need for preventing major infectious disease or rare disease).

9

Target(s)

/

10

Indication(s)

Previously approved:

1. For treating rheumatoid arthritis;

2. Hepatic fibrosis;

Newly approved on Aug. 18, 2022:

3. Chronic granulomatous disease (CGD).

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Grace Wang
ChemLinked Regulatory Analyst
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